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FDA 510(k) Application Details - K090300
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K090300
Device Name
Pump, Infusion, Elastomeric
Applicant
ACE MEDICAL US, LLC
9102 TURFWAY BEND DR.
POWELL, OH 43065 US
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Contact
ANDREW LAMBORNE
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
MEB
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More FDA Info for this Product Code
Date Received
02/06/2009
Decision Date
04/30/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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